A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis

Ahn-Gook Pharmaceuticals Co.,Ltd1 site in 1 country220 target enrollmentOctober 17, 2019

ConditionsAcute Bronchitis

InterventionsAGU (Active Comparator)AGS (Experimental)

DrugsAGS (Experimental)AGU (Active Comparator)

Overview

Phase: Phase 3
Intervention: AGU (Active Comparator)
Conditions: Acute Bronchitis
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Enrollment: 220
Locations: 1
Primary Endpoint: Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis

Registry

clinicaltrials.gov

Start Date

October 17, 2019

End Date

July 29, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Both gender, 19 years ≤ age ≤ 75 years
•BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
•Patients without fever based on Visit 2(Randomized Visit)
•Those who can comply with the requirements of clinical trials
•Written consent voluntarily to participate in this clinical trial

Exclusion Criteria

•Patients with respiratory and systemic infections requiring systemic antibiotic therapy
•Patients with bleeding tendency or coagulation disorder
•Patients who investigators determines to severe respiratory disease that would interfere with study assessment
•Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
•In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons

Arms & Interventions

AGU (Active Comparator)

Placebo of AGS + AGU

Intervention: AGU (Active Comparator)

AGS (Experimental)

AGS + Placebo of AGU

Intervention: AGS (Experimental)

Outcomes

Primary Outcomes

Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2

Time Frame: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)

The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe

Secondary Outcomes

Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2(7days)
Treatment response rate at Visit 3(7days)
Integrative Medicine Outcome Scale (IMOS)(7days)
Integrative Medicine Patient Satisfaction Scale (IMPSS)(7days)